{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221928",
      "product_res_number": "Z-3215-2026",
      "event_date_initiated": "2026-08-06",
      "event_date_posted": "2026-09-18",
      "recall_status": "Open, Classified",
      "res_event_number": "99595",
      "product_code": "OBO",
      "k_numbers": [
        "K181594"
      ],
      "product_description": "Brand Name: Heidelberg Engineering GmbH\nProduct Name: SPECTRALIS with Flex Module\nModel/Catalog Number: S3610, S2610, S2000, S1610\n\nmultimodal imaging platform optimized for the posterior segment of the eye",
      "code_info": "UDI-DI 04059237000235 \n\nLot Code: Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, Spec-24611",
      "firm_fei_number": "3002807157",
      "recalling_firm": "Heidelberg Engineering GmbH",
      "address_1": "Max-Jarecki-Str. 8 8 max-jarecki-str.",
      "city": "Heidelberg",
      "country": "Germany",
      "reason_for_recall": "Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.",
      "root_cause_description": "Component design/selection",
      "action": "Firm began notifying US customers on August 6, 2026 via email.\n\nInstruction to Customers: There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose when the Flex Module is being pulled or pushed during movement or transportation, affecting the stability of the stand. As a result, the Flex stand may tip over if not correctly handled or supported by the operator.\n\nUsers shall schedule a service appointment with your Heidelberg Engineering service partner as soon as possible so that the castor fastenings can be inspected and, if necessary, corrected.",
      "product_quantity": "87",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.",
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          "K230897",
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          "K190732",
          "K071839",
          "K071250",
          "K231673",
          "K132323",
          "K201252",
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        ],
        "registration_number": [
          "9617167",
          "3008348697",
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          "9614661",
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          "3004026651",
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        ],
        "fei_number": [
          "3002785343",
          "3008348697",
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          "3003060634",
          "1000114111"
        ],
        "device_name": "Tomography, Optical Coherence",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1570",
        "device_class": "2"
      }
    }
  ]
}